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Adverse drug events a large burden in pediatric care

National data indicate more than half a million ambulatory visits per year for side effects, accidental overdoses

September 28, 2009

Boston, Mass. - An 11-year national analysis at Children's Hospital Boston shows that side effects or accidental overdoses of medications are a common complication of outpatient care in children, generating more than half a million additional visits per year, particularly in children age 4 and younger. Findings are reported in the October issue of Pediatrics.

While many studies have documented adverse drug events, or ADEs, in adults, information in children has been limited, despite the fact that drugs are prescribed to children in almost 70 percent of outpatient visits (1). According to the American Academy of Pediatrics, 75 percent of drugs given to children have not undergone pediatric testing (2).

The researchers, led by Florence Bourgeois, MD, MPH, of Children's Division of Emergency Medicine, analyzed data from the National Center for Health Statisticson outpatient visits throughout the United States. Focusing on children up to age 18, they tallied an average of 585,922 visits per year for ADEs between 1995 and 2005. Most of these visits were to outpatient clinics, but 22 percent were to emergency rooms.

The authors suggest that clinicians need to be aware of potential adverse effects and provide appropriate anticipatory guidance to parents, especially when children are given a medication for the first time. "We found that there are as many as 13 outpatient visits for adverse drug events per 1,000 children, indicating that they are a common complication of pediatric care," says Bourgeois.

Children 4 years and younger made the most visits (43 percent), followed by children 15 to18 years old (23 percent). The most frequent side effects were skin-related or gastrointestinal, present in 45 and 16.5 percent of children, respectively. 52 percent of the children had symptoms suggesting an allergic reaction.

Antimicrobials (such as penicillin) were the most frequently implicated drugs, accounting for 27.5 percent of visits overall, and as many as 40 percent of visits among children 0-4 years old. They were followed by neurologic/psychotropic medications (6.5 percent) and hormones (6 percent). The last two categories accounted for the most ADE visits among older children, likely reflecting the increase in medication therapy for emotional and behavioral disorders during the adolescent years, and prescriptions of contraceptives for teenage girls.

Recent data from the National Center for Health Statistics and the Slone Survey indicate that as many as 56 percent of children have taken at least one medication during the preceding week, with 26 percent using two or more medications and more than 20 percent using a prescription drug.

"One approach to reducing adverse events is to ensure that clinicians have ready access to complete information on the adverse effects and comparative effectiveness of medications," says Bourgeois. "This information should derive from data on the real-world use of the drugs, not just from the package inserts."

To the authors' knowledge, this is the first study to comprehensively examine ADEs occurring in the outpatient setting. It was funded by an R01 Grant from the National Library of Medicine and a T32 Grant from the National Institute of Child Health and Human Development.

Children's Hospital Boston is home to the world's largest research enterprise based at a pediatric medical center, where its discoveries have benefited both children and adults since 1869. More than 500 scientists, including eight members of the National Academy of Sciences, 12 members of the Institute of Medicine and 12 members of the Howard Hughes Medical Institute comprise Children's research community. Founded as a 20-bed hospital for children, Children's Hospital Boston today is a 396-bed comprehensive center for pediatric and adolescent health care grounded in the values of excellence in patient care and sensitivity to the complex needs and diversity of children and families. Children's also is the primary pediatric teaching affiliate of Harvard Medical School. For more information about the hospital and its research visit: www.childrenshospital.org/newsroom.

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